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Assessment of Initial Efficacy and Safety of High Intensity Focused Ultrasound 'ExAblate 4000 Type 2' for Blood Brain Barrier Disruption in Patients With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04526262
Recruitment Status : Active, not recruiting
First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:

The proposed study is to evaluate initial efficacy and safety of the BBB disruption with transcranial MRI-guided focused ultrasound (ExAblate 4000 type 2.0) in patients with Alzheimer's disease.

This study iw designed as a prospective, single-site, single-aarm, nonrandomized study. Assessments will be made before and three months after 2 sessions of BBB disruption with radiologic, nuclear medicine imaging and neurophysiological examinations. Relative safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: transcranial magnetic resonance guided focused ultrasound BBB disruption Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-center, Open, Prospective, Single-arm, Feasibility, Investigator-initiated Trail for Assessment of Initial Efficacy and Safety of High Intensity Focused Ultrasound 'ExAblate 4000 Type 2' for Blood Brain Barrier Disruption in Patients With Alzheimer's Disease
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BBB disruption
All participant in this arm will undergo 2 sessions of transcranial magnetic resonance guided focused ultrasound blood brain barrier disruption every 3 months.
 Device: transcranial magnetic resonance guided focused ultrasound BBB disruption
The ExAblate BBB disruption procedure will be performed with ExAblate 4000 type 2.0 system, and this will be performed twice every 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events safety profile [ Time Frame: 6 months ]
    The type and severity of post-procedure adverse events will be assessed for overall safety. Safety of the BBBD procedure will be evaluated through patient examination and MRI assessements during the treatment and by their standard care of follow-up MRI scans and clinical visits.


Secondary Outcome Measures :
  1. Efficacy of BBB disruption : evaluated by radiologic imaging [ Time Frame: 6 months ]
    The efficacy of BBB disruption in Alzheimer's disease will be evaluated by radiologic, nuclear medicine imaging and neurophysiological examination.

  2. Efficacy of BBB disruption : evaluated by nuclear medicine imaging [ Time Frame: 6 months ]
    The efficacy of BBB disruption in Alzheimer's disease will be evaluated by radiologic, nuclear medicine imaging and neurophysiological examination.

  3. Efficacy of BBB disruption : evaluated by neurophysiological examination [ Time Frame: 6 months ]
    The efficacy of BBB disruption in Alzheimer's disease will be evaluated by radiologic, nuclear medicine imaging and neurophysiological examination.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 50 and 85 years, inclusive.
  • Total score of 23 or less on the Korean version of Mini Mental state Exam (K-MMSE)
  • FBB (18F-Florbetaben)-PET test result positive
  • FDB (18F-Fluorodeoxyglucose)-PET test results suspected of Alzheimer disease-induced neurodegeneration
  • Mild cognitive impairment or dementia caused by Alzheimer's disease
  • A participant who has been given a drug at a stable dose for at least three months to improve symptoms of Alzheimer's disease
  • Able to communicate during the ExAblate BBB disruption procedure
  • Able and willing to give informed consent
  • Able to attend all study visits

Exclusion Criteria:

  • CGA-NPI (Caregiver-Administrated Neuropsychiatry Inventory) severity score of more than 2 points for any of "Delusion", "Hallucination" or "Agitation/Aggression"
  • Known sensitivity/allergy or contraindications to MRI contrast agent(Gadovist®) or the ultrasound contrast agent (Definity®)
  • Contraindications to MRI such as non-MRI compatible implanted devices.

  • Any of the following items in MRI

    1. severe ischemic changes
    2. active or chronic infection/inflammation
    3. acute or chronic hemorrhage
    4. tumor/space occupying lesion
    5. meningeal enhancement
    6. intracranial hypotension
  • More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
  • Active seizure disorder or epilepsy (seizures despite medical treatment)
  • History of a bleeding disorder, coagulopathy
  • Cardiac disease or unstable hemodynamics
  • Severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2
  • Severe brain atrophy
  • HIV (Human immunodeficiency virus) positive, who have a high probability of developing HIV encephalitis due to the influx of HIV in to the brain parenchyma
  • Subjects with evidence of cranial or systemic infection
  • A homozygosity of Apolipoprotein E allele (ApoE4) known to have a thin blood-brain barrier
  • Positive pregnancy test (women of childbearing potential)
  • A participant in other clinical trials or have experience in other clinical trials within 90 days from the screening date
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526262


Locations
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Korea, Republic of
Department of Neurosurgery, Yonsei University College of Medici
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jin Woo Chang Severance Hospital
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04526262    
Other Study ID Numbers: 1-2019-0095
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders